Multiple studies have documented the staggering prevalence of Hospital Acquired Infections (HAI's). When compared to automobile crash fatality data, hospitalized patients are 2.4 times more likely to die from a HAI than from a road accident. The Center for Disease Control (CDC) ranks HAI's among the top 10 leading causes of death in the U.S. In fact, the CDC also states that nearly 2 million HAI's are contracted each year, leading to nearly 100,000 deaths. Of these 2 million HAI's, approximately 850,000 are classified as Catheter-Associated Infections (CAI's).
According to CDC surveillance criteria, 50,000 of these CAI's are further categorized as Catheter Associated Bacteremia's (CAB's). The case fatality rate for CAB's is more than 20% (10,000 deaths/50,000 cases) with an attributable mortality rate of 35%. Essentially, any time a patient undergoes intravenous therapy and develops complications that result in death, 35% of that patient's death can be attributed to the presence of an intravenous catheter. CAB's primarily occur from poor aseptic technique, ultimately leading to contamination of intravenous catheter access ports during medication administration.
Besides the staggering mortality statistics, the healthcare costs for treating HAI's are monumental. Just one patient with a CAI can increase treatment costs by $45,800 and increase their hospital length of stay by an average of 10.4 days. Overall, it is estimated that HAI's cost acute-care hospitals between $35 and $45 billion annually. Furthermore, total direct, indirect, and non-medical social costs of HAI's are estimated at around $96 to $147 billion annually, including loss of work, legal costs, and other patient factors.
As recommended by the CDC, more than 80% of intravenous access devices are needle-free, meaning they use a Needle-less Connector (NC), also known as a port, or NC port. NC's provide easy access points for medication infusion connections or injections. A syringe can easily be screwed onto the NC, then medications can be delivered via the venous blood system (either peripherally or centrally).
Although the NC is convenient to use, it is not without an inherent problem. The NC port is among the many documented vectors for microbe transmission and listed as the primary source for most pathogens causing endemic CAI's. Bacterial colonization of the NC port can lead to bloodstream infections known as Catheter Associated Bloodstream Infections (CABSI) or Central Line Associated Bloodstream Infections (CLABSI), both being specific types of CAB's.
Over the years, needle safety concerns for the healthcare worker has led to the current design of the NC. Although the NC has effectively halted accidental needle sticks by healthcare workers, it has posed a new problem—contamination of the NC itself. Risk factors for contamination include air contaminants, contamination from the patient's own flora (clothing, bedding, dressings), or from healthcare workers' hands during medication administration. Human error of the healthcare worker results from poor adherence to aseptic technique secondary to inconsistent staff education and training. Even basic hand-washing compliance rates are between 25-50%. Unfortunately, very few procedural changes have been implemented that protect the access ports and address the problem of human error.
Furthermore, the design of the NC port itself also plays a crucial role in microbe transmission. Current designs are not intuitive, therefore the intuitive sense to disinfect the port surface prior to medication administration is lost. Just one omission of disinfecting the port prior to access permits bacterial entry, attachment, and biofilm formation, allowing bacteria to strengthen prior to release into the bloodstream. Once a catheter port is contaminated, infections result from bacterial seeding during manipulation of the port or catheter junctions. IV tubing may also become inadvertently contaminated when allowed to drape onto the floor or when placed next to the patient in bed. Once contaminated, bacterial ingress into the catheter lumen is considered the cause of 50% of post-insertion catheter-related infections.
The Association for Professionals in Infection Control defines disinfection as a process to eliminate micro-organisms with the use of liquid chemicals or pasteurizing. This process is only effective by having proper contact time with the intended surface. CDC recommendations and the Infection Nurses Society state that the clinician should minimize contamination risk by disinfecting the access ports using friction with and appropriate disinfectant (70% alcohol, chlorhexidine, or povidone iodine) prior to each access of an intravascular device.
Multiple studies demonstrate that infections are drastically lowered or eliminated by disinfecting the access ports prior to use, or by even covering the access ports with an anti-microbial cap when not in use. The disadvantages of the anti-microbial cap requirement is that they can be cumbersome to screw on, and they are a one-time use item. Currently, intravenous tubing sets require multiple anti-microbial caps. In turn, this necessitates a rather large supply of them to be readily available during routine use. This only further decreases the likelihood of adherence to disinfection compliance.
Alcohol wipes are the most commonly used item to disinfect the access port. However, these wipes have been proven both effective and ineffective at disinfection times ranging from 5-60 seconds. Like the protective caps, a ready supply of wipes is required for effectiveness, but they can easily be forgotten at the bedside by the clinician. Isopropyl alcohol combined with chlorhexidine is more effective than either agent alone, but the effectiveness is only achieved after the liquids have dried. When these ports are utilized, the reality is that not every clinician swabs, or allows for adequate drying time of these agents for a number of reasons. Non-compliance can result from excessive workloads, increasing age of the clinician, the workplace culture, emergency situations, and failure to simply bring alcohol wipes to the bedside.
Currently, the problem of port contamination is only being addressed from a circumferential perspective. Conclusions in the literature continue to simply suggest that healthcare workers maintain vigilance with proper hand hygiene, alcohol swabbing, and until just recently, adding a protective cap to the IV port. However, even when using this protective cap, the port is still required to be cleaned after cap removal with an alcohol swab prior to use. Another problem is that no specific phase of patient care is ever identified as the sentinel cause of an HAI. For example, a blood-stream infection from a port contaminated pre-operatively, or even during surgery, may not reveal itself until days later. Therefore, real-time feedback of when the port was contaminated cannot be obtained.
Throughout a patient's surgical experience, multiple nurses as well as anesthesia personnel will have accessed that patient's IV ports multiple times while injecting medications. Since the pre-operative phase of care is where the potential for contamination is first encountered, it is imperative that the focus of port contamination should be shifted to initial patient contact and the environment that the IV ports are exposed to. This is where patients get their IV needle inserted, the intravenous tubing is taken out of its sterile packaging, spiked into a bag of fluids, and is then connected to the IV catheter. As the tubing and access ports are lying next to the patient, they are already rendered contaminated. This is because there is no physical barrier in place that keeps the individual ports free from the bacteria-ridden environment. More times than not, the patient will take their IV bag and tubing to the restroom with them, thus dragging the tubing and access ports along the floor. Once back in bed, the ports are further exposed to the patient's own flora and their bedding. All of these bacterial environments are encountered prior to the patient even going to the operating room (OR), posing a significant risk of contamination from the outset.
Anesthesiologists and Nurse Anesthetists are one of the first providers that patients encounter. Therefore, common sense dictates that anesthesia personnel can and should play an active role in the prevention of HAI's. When a patient is prepped for surgery, the Anesthetist starts a free-flowing IV line and administers several pre-operative medications (sedatives, antibiotics, and anti-nausea medications) via the NC ports prior to transfer to the OR. Anesthesia providers are also in frequent contact with the patient's skin and mucosa during surgery, and repeatedly access the blood-stream while administering medications, fluids, and obtaining blood samples. During surgery, the access ports are also often left exposed. This can allow direct contact to blood, urine, fecal matter, and gastric fluids. Many times the main manifold hub even inadvertently falls onto the OR floor, further exposing the patient to a host of bacteria. Also, at critical moments, medications need to be given rapidly, and it is not feasible to swab access ports and wait for a drying time prior to administering critical medications.
Although anesthesia safety itself has improved over the past decades, studies have found that anesthesia professionals have the lowest compliance with hand hygiene recommendations across all medical specialties. Major bacterial pathogens have been identified on the hands of Anesthetists even prior to patient contact. These pathogens can ultimately lead to a contaminated work environment. A recent study showed that transmission of bacteria to IV access ports occurs 32% more frequently and that transfer of certain bacteria occurs in less than 5 minutes during anesthesia care. In a typical anesthesia procedure, there are up to 60 opportunities for hand hygiene, although the typical anesthesia provider performs hand hygiene less than once per hour during a procedure.
After surgery, the patient is taken to the recovery unit. Once there, the current procedure is for the existing free-flowing IV tubing to be changed out for tubing that functions on an IV pump, thus regulating the amount of fluids that a patient receives. Like the pre-operative scenario, this new tubing is exposed to pathogens on the patient, the bed, bandages, etc. Then, post-operative medications are given via potentially contaminated IV ports. After the recovery phase, the patient is transferred to a hospital bed. This is where the patient will encounter yet another team of nurses who will provide more medication injections. This will continue exposing the patient to the possibility of developing an infection directly related to routine access of the IV tubing. The only defense that currently exists is the clinician that rigorously adheres to protocol; basic hand-washing technique, swabbing access ports, waiting for a dry time, and then re-covering the ports with a new protective cap. However, as the literature shows, this is not a realistic expectation.
Since patients move through each phase of care within a matter of hours, one can easily see that the specific moment of port contamination can be difficult to identify. Therefore, it is imperative that the potential for contamination be addressed from a ground-zero approach. This invention is designed to provide both a physical and chemical layer of protection in a unique way that does not currently exist. This will help the clinician to keep IV ports disinfected throughout a patient's hospital stay. With its innovative design, it comprehensively addresses the contaminations risks inherent in the pre-operative, surgical, and post-operative phases of care. Use of this invention will also serve as a reminder to the clinician and the patient, that prevention of infection is a continuous, real-time process. The end goal is to reduce the number of IV port contaminants, and ultimately reduce the number of CAI's seen within healthcare today.
For the foregoing reasons, there is a need for a device which physically covers the IV ports and also can provide continuous chemical disinfection.